Isicotecnologie.it

Reliability of the Scoliosis Research Society-22 Patient Questionnaire (Italian version)in mild adolescent vertebral deformities
M. MONTICONE 1, R. CARABALONA 2, S. NEGRINI 1 2
Aim. The reliability evaluation of the Italian version of1ISICO (Italian Scientific Spine Institute), Milan, Italythe Scoliosis Research Society-22 Patient Questionnaire2Unit of Functional Rehabilitation(SRS-22-I), administered to adolescents with mild verte-Don Gnocchi Foundation, Milan, Italybral deformities, is evaluated.Methods. Study design: forward-backward translation,pretest, final version according to a focus-group evalu-ation, and 1 week test/retest. Population: pretest: 35subjects (22 females), age range 8.5-19 years, 28 idiopath-ic scoliosis (17°±7°), 7 hyperkyphosis (54°±4°); test/retest:ent type. Lack of reliability for questions 12 and 2120 subjects (11 females), age range 12-17.5 years, 15should be better understood. Until now the psychomet-idiopathic scoliosis (16°±8°), 5 hyperkyphosis (55°±5°).ric properties of SRS-22 questionnaire have been evalu-Statistical analysis: Spearman rank test, percent of agree-ated only in USA populations, and in idiopathic scolio-ment. Statistical significance: 0.05. Software: Statgraphicssis. Moreover, only one study has been proposed includ-3.0. We calculated the results of the questionnaire anding patients with mild idiopathic scoliosis. This, togeth-performed the statistical analysis using non parametricer with the non-parametric statistical analysis used,test because of the charcteristics of the data: this differcould explain the high ceiling and floor effects we foundfrom previously published results.in our data.Results. Response rate was 100%. Total score: median 4
Key words: Scoliosis - Rehabilitation - Questionnaires.(range 3-5); results for different domains (median,range): function/activity 4 (3-5), pain 5 (3-5), self image/appearance 3 (2-5), mental health 4 (3-5), satisfactionwith management 4 (2-5). Time required to answer the
Once diagnosed, idiopathic scoliosis can develop
during adolescence in more than 85% of cases 1, 2
questionnaire ranged from 5 to 20’; for 12 to 17.5 yearsold subjects from 5 to 10’. pretest showed difficulties
and requires treatment to be stopped. Both surgical
with questions on pain; the questionnaire was changed
and conservative treatments cause, respectively, per-
accordingly. Spearman’s rho ranged from 0.42 to 1, not
manent and transient disability, having a high psy-
significantly different from null value for questions 12
chological impact, often underestimated by health
and 21. Percent of agreement (evaluated only for ques-
professions, even if they are relevant for patients and
tion 11a) was 100%. The ceiling and floor effects havebeen found high.
To entirely understand the scoliosis problem we
Conclusion. The SRS-22-I was found to be reliable foryoung patients with mild vertebral deformities of differ-
have to go beyond its biological aspects, consideringthe adolescent’s point of view, that is the most impor-
Submitted for publication July 20, 2004.
tant to obtain a good compliance to the treatment.
Patients’ perceptions of several aspects of their healthcondition and the outcome of its management are cru-
Address reprint requests to: S. Negrini, ISICO (Istituto Scientifico
cial for final results.4 Anyway, these results go beyond
Italiano Colonna Vertebrale), Via Carlo Crivelli 20, 20122 Milano. E-mail:[email protected]
the simple clinical and, above all, strictly radiological
RELIABILITY OF THE SCOLIOSIS RESEARCH SOCIETY-22 PATIENT QUESTIONNAIRE (ITALIAN VERSION)
evaluation.5 These results can be assessed by health
from 5 (best) to 1 (worst).14 The SRS-22 patient ques-
related quality of life (HRQL) questionnaires: much
tionnaire gained good score distribution, internal con-
remains to be discovered about population health in
sistency, reproducibility, concurrent and discriminant
comprehensive terms of functional health and well-
validity,14, 15 being shorter and more focused on the
being, regarding the relative burden of disease, and the
health issues related to adolescent idiopathic scolio-
specific benefits of selected treatments.5
sis (AIS) than SF-36. The SRS-22 patient questionnaire
Advances and in-depth research have been large-
obtained a satisfying level of acceptance to be used
ly conducted over these last few years for finding sat-
and safely developed in pre/post surgical AIS English-
isfying methods able to describe patients’ subjective
speaking patients, for both clinical and research deci-
health status perceptions: today several valid and reli-
able patient-based tools are available. The most
The aim of this study was to develop an Italian ver-
famous and world-known is the SF-36,6 which has
sion of the Scoliosis Research Society-22 Patient
been employed in more than 1 000 indexed studies,
Questionnaire (SRS-22-I), and to verify its reliability
and adopted because of its brevity and of its com-
and applicability in Italian adolescents with mild ver-
prehensiveness.7 The usefulness of the SF-36 in esti-
tebral deformities in everyday clinical practice.
mating disease burden is illustrated in many articlesdescribing more than 130 diseases and conditions:among the most frequent, with more than 20 SF-36
Materials and methods
English-speaking publications each, are arthritis, backpain, depression, hypertension and diabetes.7 Trans-
We performed a forward-backward translation of
lation, subsequent validation and reliability studies
the English version of the questionnaire, made both by
gave rise to many other indexed and not-indexed arti-
an expert of scoliosis and a mother-tongue translator:
a focus-group evaluation (group composed by sen-
The SF-36 is a generic HRQL questionnaire, but in
ior and junior researchers, translator and statistician)
specific diseases the usefulness of specific HRQL eval-uations has been shown. In the field of scoliosis treat-
produced the first version of the questionnaire. A
ment, many efforts in this direction have been made
pretest assessment was performed on the pretest group
by the Scoliosis Research Society.11 The original
(PTG): self-compiled the questionnaire in presence of
Scoliosis Research Society HRQL questionnaire has
one researcher, which was there to receive his sugges-
been first produced by Haher et al. in 1999 12 to pro-
tions and identify his difficulties with any single ques-
vide a simple, direct, disease-specific, patient-based
tions. Consequently, the actual version of the question-
assessment for patients with idiopathic scoliosis. This
naire (named SRS-22-I, Appendix A) was produced
first HRQL questionnaire demonstrated satisfactory
after a second focus group evaluation (group now
internal consistency for all 7 domains and reproducibil-
composed by senior and junior researchers, and sta-
ity for 3 of the domains in which it was divided.12
tistician): its reliability was finally evaluated through
Anyway, this HRQL scoliosis questionnaire needed
test-retest in a second sample of patients, the test/-
important improvements and modifications in the fol-
retest group (TTG). In this phase, according to the
original instructions, the questionnaire was self-com-
The results of these changes led to the Scoliosis
piled by the patients together with their parents in the
Research Society-22 Patient Questionnaire (SRS-22),
waiting room, immediately after medical evaluation.
published in the past year by Asher et al.14-16 This
Patients were asked to answer with no more instruc-
new questionnaire, named SRS-22 Patient Question-
tions then those written on top of the questionnaire.
naire, includes 5 domains. The domains and the num-
The help of a researcher was available, but never
ber of the questions (reported in parenthesis) in each
required. Retest was performed at home after 7 days.
domain are the following: function/activity (5), pain
The complete characteristics of PTG and TTG are
(5), self-image/appearance (5), mental health (5) and
satisfaction with management (2). The combination of
Due to the nominal or ordinal nature of our data,17
the first 4 domains is labelled subtotal. The mental
we choose to perform the statistical analysis according
health questions were adapted with permission from
to a nonparametric approach using Spearman rank
SF-36. For each question, the scoring scale ranged
test (percent of agreement for question 11A and 11B).
RELIABILITY OF THE SCOLIOSIS RESEARCH SOCIETY-22 PATIENT QUESTIONNAIRE (ITALIAN VERSION)
TABLE I.—Characteristics of the population.
TABLE III.—Statistical results of test/retest evaluation.
TABLE II.—Question 11: comparison of the English and Italian
11. Which one of the following 11. A) Utilizzi farmaci per la tua
— Non-narcotics weekly or less 11. B) Se hai risposto sì, quali?
fore the instructions for compilation and the ques-
tions 1, 2, 7, 12, 13, 19, and 20 were slightly changed,while the questions 5, 6, 10 and 11 were completely
Statistical significance was set at 0.05. Software used
changed to produce the final version. All these vari-
included Excel 7.0 and Statgraphics 3.0.
ations were related only to the translation of the ques-tionnaire and did not change its general structure,with only one possible exception: in fact, the wayquestion 11 was asked in English could not be pro-
posed in Italian without medical explanations andwe changed it slightly from the original (Table II).
The response rate was 100% in both populations
The subjects required no explanations during the
and time required to answer the questionnaire ranged
test phase. In the TTG, Spearman’s rho ranged from
from 5 to 20 s in the PTG (which included also young-
0.42 to 1, and it was not significantly different from null
er subjects) and from 5 to 10 s in the TTG.
value for questions 12 and 21, belonging, respective-
During the pretest phase, patients gave some sug-
ly, to function/activity and satisfaction with manage-
gestions on the way questions had been written: there-
ment domains (Table III): it must be considered that
RELIABILITY OF THE SCOLIOSIS RESEARCH SOCIETY-22 PATIENT QUESTIONNAIRE (ITALIAN VERSION)
the p-value for question 12 was 0.06. Percent of agree-
changed accordingly. May be this could depend on the
ment was evaluated only for question 11a, where all
fact that our target was strictly mild idiopathic scoli-
subjects answered “no”, and was 100%. The floor/ceil-
osis: in this phase, pain is not as frequent as in the pre-
ing effect we found are reported in Table IV, compared
surgical (or postsurgical) phase can be.
with those of the original USA version (the last one
The questionnaire showed to be repeatable, with the
have been obtained using the average to calculate
exceptions of question 12 and 21. As happened in the
the domains, while in our results we used the medi-
original SRS-22 version,14 the SRS-22-I demonstrated to
an, coherently with the data analyzed).
be easily understandable and answerable in time (also
Looking at the results from a clinical point of view,
for younger patients), repeatable, and reliable.
the total score (median, range) was 4 (3-5), while the
Asher et al. too found difficulties in the assessment
results for the 5 different domains were, respectively:
of satisfaction with treatment 15 (question 21) but there
function/activity 4 (range 3-5), pain 5 (3-5), self
are differences with the previous study: all our patients
image/appearance 3 (2-5), mental health 4 (3-5), sat-
underwent conservative treatment (only exercise or
exercise and brace treatment) and not also surgery;moreover, the questionnaires were self-compiled andnot administered through interviews made by the sur-
Discussion and conclusions
geons. Anyway, in our study we had a change of set-ting (compilation at home vs in the waiting room of
Scoliosis treatment cannot longer be considered
the Scoliosis Centre) that could drive to variations
(as) only a mere radiographic treatment: there are
when asking about satisfaction with treatment (ques-
core aspects such as patients’ satisfaction, psycholog-
tion 21), but also when looking at interference with
ical problems, quality of life etc.,4 that all need to be
everyday home activities (question 12). In this last
case, it is also possible that the questionnaire pro-
The well-known SF-36 is a useful instrument for
duced attention to changes not even discovered
studying general population, individuating the relative
before, or that the results of the visit drove to chang-
burden of diseases, differentiating the health benefits
es in everyday life not understood immediately after
produced by a wide range of different treatments,
the medical evaluation. Nevertheless, even if the ten-
and screening different patients.7 However, the SF-
dency toward significance of question 12 was clear,
36 is a multipurpose, generic health survey, that yields
our results in this case should be deepened in future
an 8-scale profile of scores as well as physical and
studies, while the answers to question 21 should be
mental health summary evaluation, opposed to ques-
tionnaires that target a specific age, disease, and treat-
When compared to Asher’s results,14 we have found
satisfying clinical results in the self-image/appear-
The latest version of the American SRS-22 patient
ance, pain and mental health domains: these results
questionnaire has been strongly advocated to go
may depend upon the fact that mild idiopathic scoli-
beyond this limits:13 this questionnaire proved to be
osis produces a lower perception of the spinal defor-
highly tailored to this particular kind of patients and
mities than presurgical conditions can determine. The
age, to their physical changes according to treatment
self-image/appearance domain of SRS-22 patient ques-
(both surgical and conservative), to their psycholog-
tionnaire is not found in SF-36 HRQL questionnaire,
ical problems, and above all to their quality of life
being of greatest importance in scoliotic patients.14
We must underline the ceiling effect we verified in our
This study has been developed with clear intents.
population, were the lowest answer was 2, and only
It may compare the Italian results with the results
in 2 domains (self image/appearance and satisfaction
existing in the original version in the effort of verify-
with management), while in the others it was 3. This
ing the reliability of this HRQL questionnaire for mild
is likely due to the low-medium degree of scoliosis
AIS Italian patients. We did not find problems during
considered in our sample: in future studies in this
the forward-backward translation phase, reaching the
kind of population this result should be taken in
final Italian version according to an expert group eval-
account, even if changing the scale could drive to
uation. Patients in the PTG demonstrated some diffi-
difficulties comparing the data internationally.
culties, and the Italian version of the questionnaire was
Another difference between our study and the pre-
RELIABILITY OF THE SCOLIOSIS RESEARCH SOCIETY-22 PATIENT QUESTIONNAIRE (ITALIAN VERSION)
vious one can be found for the age: Asher’s results
References
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In conclusion, the SRS-22-I was found to be reliable
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only one study has been proposed including patients
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RELIABILITY OF THE SCOLIOSIS RESEARCH SOCIETY-22 PATIENT QUESTIONNAIRE (ITALIAN VERSION)
APPENDICE AQuestionario SRS-22 - Versione Italiana
Istruzioni: stiamo valutando le condizioni di salute della tua schiena ed è perciò importante
che tu risponda a ognuna di queste domande da solo.
Per favore, segna per ogni domanda la risposta che ritieni più adeguata
1. Quale termine descrive meglio il dolore di cui hai
6. Qual è il tuo aspetto quando sei vestito/a?
7. Negli ultimi 6 mesi sei stato/a così depresso/a da
2. Quale termine descrive meglio il dolore di cui hai
3. Durante gli ultimi 6 mesi sei stato/a molto ner-
4. Se l’aspetto estetico della tua schiena dovesse
9. Qual è il tuo attuale livello di attività lavorativa/
restare quello attuale per il resto della tua vita,
10. Quale di questi termini meglio descrive l'aspetto
5. Riesci a fare normalmente le tue attività quoti-
del tuo tronco (ossia del tuo corpo, esclusi la tes-
❏ faccio qualunque cosa senza limitazioni
RELIABILITY OF THE SCOLIOSIS RESEARCH SOCIETY-22 PATIENT QUESTIONNAIRE (ITALIAN VERSION)
11. A. Utilizzi farmaci per la tua schiena?
17. Negli ultimi 3 mesi ti sei mai assentato/a dal
lavoro/scuola per il mal di schiena e se così è sta-
11. C. Se hai risposto sì, con che frequenza?
12. La tua schiena limita in qualche modo le tue atti-
18. Esci di più o di meno rispetto ai tuoi amici?
13. Ti sei sentito/a calmo/a e tranquillo/a negli ultimi
19. Data la condizione attuale della tua schiena ti sen-
14. Pensi che la condizione della tua schiena inter-
20. Sei stato/a felice negli ultimi 6 mesi?
15. Tu e/o la tua famiglia state vivendo delle diffi-
21. Sei soddisfatto dei risultati del trattamento della tua
coltà economiche a causa della tua schiena?
16. Negli ultimi 6 mesi ti sei mai sentito/a disperato/a
22. Ti sottoporresti ancora allo stesso trattamento se